Using Vitamin D3 to prevent recurrent urinary tract infections

Phase II Clinical Trial of Vitamin D3 for Reducing Recurrence of Recurrent Lower Urinary Tract Infections: a Multicenter, Randomized, Placebo-controlled Trial

This study is testing if taking Vitamin D3 can help adults who frequently get urinary tract infections by seeing which dose works best to prevent them.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zensun Sci. & Tech. Co., Ltd. (Industry-sponsored)
• Locations: 6 sites (Xi'an, Shaanxi and 5 other locations)
• Trial ID: NCT04859621 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of Vitamin D3 in reducing the recurrence of lower urinary tract infections (rUTIs) in adults. Participants will receive either Vitamin D3 at doses of 4000 IU or 2000 IU, a placebo, or standard antibiotic therapy. The study aims to determine the optimal dosage of Vitamin D3 that can enhance the body's natural antimicrobial peptides, potentially reducing the frequency of rUTIs. The trial includes adults aged 18 to 75 who have experienced multiple episodes of UTIs within the past year.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 who have had at least three episodes of lower urinary tract infections in the past year.

Not a fit: Patients with serious underlying health conditions or poorly controlled diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel, non-antibiotic approach to significantly reduce the recurrence of urinary tract infections.

How similar studies have performed: Other studies have shown promising results with Vitamin D3 in enhancing immune responses, but this specific approach for rUTIs is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Male or female aged 18 to 75 years, including 18 and 75 years;
2. at least 3 episodes of lower urinary tract infection in the last 12 months or at least 2 episodes of lower urinary tract infection in the last 6 months;
3. The symptoms of the latest recurrence of lower urinary tract infection have disappeared after treatment, and the treatment dosage of antibiotics has been stopped, and at least one of the following two conditions has been met:A) The middle urinary bacterial culture is less than 10\^5 CFU/mL (accept the examination results after the last improvement);B) Urine white blood cell count is less than 5 /HP, and if it can be measured in routine urine examination, it should be less than 25 /μL;
4. Signed written informed consent;
5. Be able to follow the research protocol.

Exclusion Criteria:

1. Complicated with cardio-cerebrovascular and hematopoietic system and other serious primary diseases;
2. Poor glycemic control (HbA1c \>7.5%) with diabetes;
3. Patients with genital tract malformation or acute genital tract infection and genital tract tumor;
4. Patients with urinary system tuberculosis and acute pyelonephritis;
5. Patients with cysto-ureteral reflux or urethral reflux;
6. Patients with polycystic kidney disease, neurogenic bladder, indwelling urethral catheterization, urinary tract stones, tumors or fibrous degeneration, etc., determined by the investigator as urinary tract obstruction;
7. Glomerular filtration rate (MDRD formula).20 mL/min/1.73m2, dialysis or kidney transplantation patients;
8. Chronic liver disease may have potential influence on liver function (bilirubin \>;1.5 times upper limit of normal value, aspartate aminotransferase or alanine aminotransferase \>2 times the upper limit of normal);
9. Patients with vitamin D3 contraindications, such as hypercalcemia, hypervitaminism, hyperphosphatemia with renal rickets, etc.;
10. Patients with diseases that affect the absorption of vitamin D3 in the small intestine, such as Crohn's disease;
11. receiving immunosuppressive agents or GT;10 mg/d glucocorticoids;
12. had received any other investigational drug therapy or participated in another interventional clinical trial within 30 days prior to screening;
13. Have a history of alcohol or drug abuse or suffer from mental illness;
14. Women of child-bearing age who have planned to become pregnant within 2 years (women of child-bearing age are defined as all women with physical ability to become pregnant), or women who are pregnant or lactating;
15. Circumstances in which subjects are judged by the investigator to be unsuitable for inclusion.

Where this trial is running

Xi'an, Shaanxi and 5 other locations

• The First Affiliated Hospital of Xi 'an Jiaotong University — Xi'an, Shaanxi, China (Recruiting)
• Shanghai Oriental Hospital — Shanghai, Shanghai, China (Recruiting)
• The Fifth People's Hospital, Shanghai — Shanghai, Shanghai, China (Recruiting)
• Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine，Chongming Branch — Shanghai, Shanghai, China (Recruiting)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Recruiting)
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Xian He, MD — Zhejiang Provincial People's Hospital
• Study coordinator: Debing Jiang

Conditions Recurrent Urinary Tract Infection; Vitamin D3; Recurrent lower urinary tract infection